UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031008 |
|---|---|
| Receipt number | R000035401 |
| Scientific Title | Near infrared Spectroscopic investigation for brain function |
| Date of disclosure of the study information | 2018/01/29 |
| Last modified on | 2024/03/27 15:06:29 |
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Basic information
Public title
Near infrared Spectroscopic investigation for brain function
Acronym
Near infrared Spectroscopic investigation for brain function
Scientific Title
Near infrared Spectroscopic investigation for brain function
Scientific Title:Acronym
Near infrared Spectroscopic investigation for brain function
Region
| Japan |
Condition
Condition
Stroke
Parkinsonism
Motor Neuron Disease
Spinocerebellar Degeneration
Peripheral Neuropathy
Spinal Cord Injury
orthopedical disease
Healthy subject
Classification by specialty
| Neurology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating cortical mechanism for regulating motor and cortical behavior using following tasks;
1:motor task
2:cognitive task
3:postural task
4:speech task
Basic objectives2
Others
Basic objectives -Others
neural mechanism
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
cortical activation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
functional neuroimaging study using functiona lnear infrared spectroscopy(fNIRS)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Stroke: more than 4 Weeks from onset, without severe(>50%) stenosis of intracranial artery
Parkinsonism: 2 of 4 clinical features (rigidity, tremor, akinesia, postural instability)
Motor Neuron Disease: with neurophysiological evidence of chronic denervation by needle EMG in 2 difference body segments
Spinocerebellar degeneration: with Chronic progressive cerebellar ataxia
Peripheral neuropathy: with neurophysiological evidence of reduced MCV/SCV, reduced CMAP/SNAP, conduction block, or reduced F-wave occurence in two different nerve
Spinal cord injury: segmental spinal cord lesion with neuroimaging evidence by MRI or myeloCT
Ortopedics diseases: with operation of upper or lower limb amputation or joint replacement
Healthy subject:without current evidence of neurological deficit and active orthopedical disease
Key exclusion criteria
Subject with dementia (MMSE<21)
subject with severe visual or hearing deficiency interfering usual communication
Target sample size
280
Research contact person
Name of lead principal investigator
| 1st name | Masahito |
| Middle name | |
| Last name | Mihara |
Organization
Kawasaki Medical School
Division name
Department of Neurology
Zip code
701-0192
Address
577 matsushima, Kurashiki, Okayama
TEL
086-462-1111
mihara@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Masahito |
| Middle name | |
| Last name | Mihara |
Organization
Kawasaki Medical School
Division name
Department of Neurology
Zip code
7010192
Address
577 matsushima, Kurashiki, Okayama
TEL
086-462-1111
Homepage URL
mihara@med.kawassaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School
Address
577 matsushima Kurashiki
Tel
086-462-1111
qqq@wwwwwww
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Investigating cortical mechanism for regulating motor and cortical behavior using following tasks, and evaluate cortical activity and behavioral results.MRI evaluation is also performed with informed consent.
1:motor task
2:cognitive task
3:postural balance task
4:speech task
Management information
Registered date
| 2018 | Year | 01 | Month | 25 | Day |
Last modified on
| 2024 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035401
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
